JOB SUMMARY
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Lead QC Analyst.
This position is responsible for performing complex laboratory analyses on APIs following strict written procedures derived from the United States Pharmacopoeia and/or other documents, to meet strict compendial and custom specifications. This work is performed under the cGMP/FDA guidelines. Independently initiate and execute analytical and systems improvement projects, and lead other analysts in such efforts, coordinating with other departments as necessary.
Responsibilities include:
- Independently author, execute and interpret laboratory experiments, analytical method and instrument validation efforts as necessary, including leading other analysts assigned to assist such efforts.
- Initiate and lead laboratory general systems improvement projects, including leading other analysts assigned to such projects.
- Train other analysts in overall laboratory processes/systems and in general and complex assays, as required.
- Oversee, interpret results and perform analytical investigations for OOS (Out-of-Specification) and atypical data. Assist in the gathering of evidence or results. Write summary reports detailing the investigation.
- In areas of ownership, coordinate with vendors and other analysts to perform routine calibration and preventive maintenance of laboratory equipment.
- Review/Revise SOPs and serve as a technical resource to ensure compliance with compendial documents.
- Review and interpret the work of other analysts.
- Participate in and follow departmental training, SOP, procedure and protocol documentation as required.
- Perform other duties as assigned.
Job Requirements and Qualifications:
Experience: 5 plus years of experience required, 10 plus years of experience preferred.
Education: Associates Degree required, Bachelor's Degree or above in Biochemistry or related discipline.
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
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